Zentiva Executive QA Role – Pharma & Chemistry Apply Online
Executive – QA
Locations: India / Ankleshwar
Time Type: Full time
Posted On: Posted Yesterday
Time Left to Apply: End Date: November 15, 2024 (30+ days left to apply)
Job Requisition ID: R2467111
KEY ACCOUNTABILITIES
- Quality Management/Continuous Improvement
- Line Clearance and shop floor compliance
- In-process checks and sampling activity
- Implementation of Zentiva corporate policies, Management and Control of Documents, such as SOPs, Master Documents, etc.
- Implementation of Complaint Investigation system at site
- Handling of Qualification and validation system, change control system, deviations
- Preparing & reviewing the Annual Product Quality Review
- Review of Batch Reworking/Reprocessing/Reincorporation Documents
- Review of Batch Manufacturing & Packing Records
- Coordination of cGMP Training activity including training of the people
- Compliance
- Ensure adherence to company Quality Standards, Local FDA, MHRA regulations, by:
- Understanding the requirements
- Performing the Gap analysis to find out the gaps in the existing system
- Preparing a compliance plan for closure of gaps
- Execution of compliance plans
- Review of completion for compliance activity
- Review of the regulatory dossiers, as and when required
- Prepare for and attend external/regulatory Quality audits
- Ensure adherence to company Quality Standards, Local FDA, MHRA regulations, by:
- Validations & Qualifications
- Preparation and review of Validation Master Plan
- Ensure validated status of all equipment, manufacturing processes, and cleaning processes
- Review of validation plans for facility/utilities/equipment/instrument/process/computer/cleaning
- Review of protocols for qualification and validation of facility/equipment/product/process
- Review and certification of validation reports after execution of validation of facility/equipment/product/process
- Documentation Control
- Preparation of quality system SOPs
- Controlled distribution and archival of documents & records
- Control of master documents
- Issuance of batch records and log books
- Assuring quality of products by:
- Ensuring SOP compliance
- Management of Events
- Controlling the changes made to facility/equipment/product/process and master documents by following change control procedure
- Investigation of Customer complaints/Recall
- Review of Batch Manufacturing & Packing Records
- Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints
- Ensuring the effectiveness review of the implemented CAPA
- Preparation of annual product quality review
- cGMP Training:
- To develop training modules and organize training in GMP
- Develop and execute the overall training program in coordination with all concerned departments
- Other:
- Preparation and review of site master file
- Coordinating with various agencies for making technical agreements
- Implementing the pest control program at Drug products
- Review of maintenance and calibration program
- Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations
Education / Experience
- Education:
- Graduate/Post Graduate in Pharmacy or Chemistry
- Experience:
- 3-8 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirements
Technical Skills & Competencies / Language
- Knowledge of GMP and regulatory requirements
- Good interpersonal skills and able to manage conflicts
- Believes and lives in company values
- Skilled in teamwork
- Must be able to present complicated technical issues in an easy and understandable manner and obtain appropriate actions.
If you are interested in this position, please visit the official job posting here to submit your application.
